On July 6, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a clarifying memorandum to certified health care facilities regarding CMS’s “expectations” for the mitigation of legionella risks. Specifically, CMS’s letter revises a prior June 2, 2017 memorandum which was emended on June 9, 2017 to clarify that the CMS requirement to reduce legionella risks in health care facility water systems included hospitals, critical access hospitals, and long-term care facilities, and was intended to provide general awareness for all health care organizations.

Legionella and Legionnaires’ Disease: On the Rise

Legionnaires’ disease is a serious type of pneumonia caused by a waterborne pathogen known as legionella. It is contracted when susceptible individuals inhale water droplets or mist containing elevated levels of legionella bacteria. The number of Legionnaires’ cases reported to the Centers for Disease Control and Prevention (CDC) has been on the rise since 2000. Health departments reported about 6,100 cases of Legionnaires’ disease in the United States in 2016; however, because Legionnaires’ disease is likely underdiagnosed, this number may underestimate the true incidence. The rate of reported cases in the United States increased by 286 percent for the period of 2000–14. Even for those persons exposed to virulent strains of the legionella bacteria, only about 5 percent contract Legionnaires’ disease. Those contracting the disease are susceptible due to some pre-existing condition or a compromised immune system. Smoking, obesity, and diabetes are also risk factors.

Foremost among the susceptible populations are the elderly, making nursing homes and senior living facilities particularly vulnerable to outbreaks. A recent review of Legionnaires’ disease outbreaks between 2000–14 revealed that 19 percent were associated with long-term care facilities and another 15 percent with hospitals. The death rate from Legionnaires’ is approximately 10 percent. Those who survive the disease may have been comatose or intubated and may have sustained serious permanent injury such as partial paralysis, brain injury, or amputated extremities following prolonged sepsis and organ failure.

New CMS Legionella Requirements: An Overview

In response to the growing understanding of the risks of legionella bacteria and the development standards to mitigate those risk, CMS is now making it crystal clear that it expects all providers to have a properly documented water management plan. At a minimum, this plan must include a facility risk assessment that:

• Identifies where legionella and other opportunistic waterborne pathogens could grow and spread in the facility water system
• Develops and implements a water management program that considers the ASHRAE 188 industry standard (ASHRAE Standard 188-2015: Legionellosis: Risk Management for Building Water Systems June 26, 2015) and the CDC Legionella toolkit (“Legionella” Centers for Disease Control and Prevention, September 14, 2017)
• Specifies testing protocols and acceptable ranges for control measures and documents the results of testing and corrective actions taken when control limits are not maintained
• Maintains compliance with other applicable federal, state, and local requirements (note that CMS does not require water cultures for legionella)

Tips for Implementation

This revised policy is effective immediately and should be communicated with all facility managers and staff associated with facility water management for any hospital, critical access hospital, nursing home, post-acute care provider, or assisted living facility subject to the CMS guidelines. Those facilities unable to demonstrate measures to minimize the risk of Legionnaires’ disease are at risk of citation for non-compliance. Beyond citations for noncompliance, the incidence of litigation arising out of Legionnaires’ disease outbreaks is rapidly increasing. Verdicts and reported settlements often exceed seven figures. Remediation costs following a full-blown outbreak are high and local health official can order a complete shutdown of affected areas. Over and above the potential economic losses is the damage caused by bad publicity.

Navigating proper water management policies, remediating contaminated systems, and defending lawsuits arising out of outbreaks requires significant experience. Goldberg Segalla’s toxic tort and health care attorneys are recognized nationally as authorities on compliance, remediation, and litigation associated with Legionella infections in facilities subject to CMS oversight. We are knowledgeable of the current statutes, laws, regulations, standards, and guidelines along with the latest scientific and medical literature. We regularly work and consult with many of the foremost experts on water management policy, legionella prevention, remediation, and infectious disease throughout the country. To learn more about the latest CMS guidelines and requirements and any other issues related to legionella prevention and compliance, please contact:

• Caroline J. Berdzik
• Thomas P. Bernier
• Andrew J. Scholz
• Or another member of the firm’s Toxic Tort or Health Care Practice Groups